Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism undergoIng Endovascular Mechanical Fragmentation and Thrombolytic Therapy (Re-Spire)

Inclusion Criteria:

• Men and women aged > 18 years
• Angiographically confirmed acute massive pulmonary embolism with involvement of Central pulmonary arteries.
• endovascular mechanical thrombus fragmentation + thrombolytic therapy (using recombinant tissue activator of plasminogen), performed for treatment of the above-mentioned pulmonary embolism in less than 48 hours before randomization. The patient should be randomized no earlier than 24 hours after procedures endovascular mechanical thrombus fragmentation + thrombolytic therapy
• Written informed consent signed by patient.

Exclusion Criteria:

• Signs of hemodynamic instability (i.e. systolic blood pressure <100 mm Hg.St. or episode of systolic blood pressure fall for ≥40 mm Hg. / or heart rate > 110 lasting more than 15 min) or need for ventilatory support within 12 hours prior to randomisation.
• The indication for oral anticoagulation, associated with others disease.
• malignant neoplasm of any location
• Contraindications to warfarin or pradaxa according to Russian Instructions for medical use of these drugs
• Indications for concomitant treatment with antiplatelet agents
• Any stroke within 6 months before randomization
• Intracranial hemorrhage in anamnesis
• Active bleeding, bleeding diathesis.
• Clinically significant bleeding within the last 30 days.
• Trauma or extensive surgery within 1 month before randomization or surgery planned in the next 6 months after randomization.
• Intracranial pathology: tumor, arteriovenous fistula or aneurysm.
• Gastrointestinal bleeding in the previous 3 months.
• Gastric ulcer or duodenal ulcer with clinical manifestations or endoscopically identified acute ulcer without signs of scarring during previous 30 days.
• Uncontrolled hypertension (systolic blood pressure> 180 mm Hg. and / or diastolic blood pressure> 100 mm.hg in patients receiving antihypertensive drugs).
• Pregnancy, lactation.
• Life expectancy <6 months.
• Clinically significant liver disease.
• Creatinine clearance (estimated by Cockcroft-Gault) <30 ml / min.
• hemoglobin level <90 g/l), thrombocytopenia <100x10^9 / L.
• Patients who, in the opinion of the researcher, are not suitable for inclusion in the study, for example, due to the low likelihood of doctor's recommendations following.
• Long-term use of NSAIDs
• Current participation in another clinical study.
• Allergic to contrast substance or radioisotope drugs used in procedures to assess endpoints of the study, which according to researchers, may be a contraindication to the implementation of these research methods.